(26 days)
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications.
Exposure may be taken with the Patient's sitting, standing, or in the prone/supine position.
The DigiX FDX System is not meant for mammography.
The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.
The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaging.
The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted X-Ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor.
The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.
The provided FDA 510(k) summary for the DigiX FDX device details its substantial equivalence to predicate devices, particularly focusing on technical and functional similarities rather than a standalone performance study with specific acceptance criteria related to diagnostic accuracy. Therefore, the response will focus on the details available within the document regarding non-clinical testing and conformity to standards, as a direct "acceptance criteria vs. reported performance" table for diagnostic metrics is not present.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity for a particular condition) and a corresponding reported device performance with numerical results. Instead, the acceptance criteria are framed in terms of:
- Conformity to recognized standards: The device must comply with various IEC and ISO standards related to electrical safety, electromagnetic compatibility, radiation protection, software life cycle, usability, and risk management.
- Meeting design requirements: Non-clinical verification testing ensures the device's functions and image performance meet its design specifications.
- Substantial equivalence: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate devices (DigiX FDX K192541 and Siemens Ysio K081722) without raising new questions of safety or effectiveness.
| Acceptance Criteria Category | Reported Device Performance / Assessment |
|---|---|
| Safety Testing | Compliance with 21 CFR Federal Performance Standards (1020.30, 1020.31) and various FDA-recognized consensus standards (IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 62304, 60601-1-6, 62366-1, ISO 14971, IEC 60825-1). Risk Analysis performed; risk control implemented to mitigate identified hazards. |
| Functional Testing | Functional testing of all motions of the system(s) with respect to design specifications. All functions met design requirements. |
| Image Performance | Image performance testing was conducted; results were included in the submission. Image performance criteria were met satisfactorily. |
| Software Verification | Software documentation for a Moderate Level of Concern software was included. Testing results support that all software specifications met acceptance criteria. Verification and Validation testing concluded no impact on safety and effectiveness from software updates. |
| Substantial Equivalence | Demonstrated by showing identical intended use, design principle, and applicable standards to the predicate and reference devices. Performance and non-clinical consideration results showed differences (e.g., appearance, user interfaces, physical dimensions, added detectors) do not raise new safety/effectiveness questions. |
| Dual Energy Subtraction | Marked as "Yes" for Subject Device, "No" for Predicate/Reference. This implies this new feature's performance and safety were evaluated to ensure it does not create new risks. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed device. Hence, clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system. Bench testing was performed to assess the device safety and effectiveness."
Therefore, there was no "test set" in the sense of patient images or clinical data used for this 510(k) submission to prove diagnostic performance. The testing was non-clinical (bench testing, verification, and validation) and focused on engineering criteria, safety, and functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert ground truth was used for this submission.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication was used for this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The DigiX FDX is an X-ray imaging system, not an AI-assisted diagnostic device for image interpretation. Its changes primarily involve hardware components (new detectors) and software GUI updates.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an X-ray system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of diagnostic ground truth. For the non-clinical testing performed, the "ground truth" would be established by engineering specifications, recognized standards, and established testing methodologies for hardware and software functionality and safety.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set for diagnostic classification.
9. How the ground truth for the training set was established
Not applicable.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.